Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
44401–44424 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 10, 2012
VERTESSA
K120327 · OTO
Caldera Medical, Inc.
Obstetrics & Gynecology · 98d
Cleared May 10, 2012
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE GLUCOSE (GLU)
K120369 · CFR
Hitachi Chemical Diagnostics, Inc.
Chemistry · 94d
Cleared May 10, 2012
GC BLUE SILICONE
K120521 · ELW
GC America, Inc.
Dental · 79d
Cleared May 10, 2012
AQUAMANTYS3 9.5 XL BIPOLAR SEALER
K120537 · GEI
Medtronic, Inc.
General & Plastic Surgery · 78d
Cleared May 10, 2012
EZSENSOR P DIGITAL INTRAORAL SENSOR
K121132 · MQB
Humanray Co,Ltd
Radiology · 27d
Cleared May 10, 2012
ELECSYS LH CALCHECK 5
K121279 · JJX
Roche Diagnostics
Chemistry · 10d
Cleared May 09, 2012
SYNSTER PEDICLE SCREW SYSTEM SYNSTER PLUS PEDICLE SCREW SYSTEM
K120353 · MNH
Bm Korea Co., Ltd.
Orthopedic · 93d
Cleared May 09, 2012
DSS STABILIZATION SYSTEM-RIGID
K120491 · MNH
Paradigm Spine, LLC
Orthopedic · 82d
Cleared May 09, 2012
LOCI CARDIAC TROPONIN-I CONTROL (LOW), LCTNI CON L
K121084 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 29d
Cleared May 08, 2012
PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY
K102841 · NHG
Pantex, Div. Bio-Analysis, Inc.
Chemistry · 587d
Cleared May 08, 2012
OPHIRA MINI SLING SYSTEM
K110420 · PAH
Promedon S.A
Gastroenterology & Urology · 449d
Cleared May 08, 2012
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR
K112266 · LYZ
Shandong Zhiyuan Medical Products...
General Hospital · 274d
Cleared May 08, 2012
VEIN-GOGH INSTRUMENT
K112334 · ONQ
Refine USA, LLC
General & Plastic Surgery · 270d
Cleared May 08, 2012
COBES SURGICAL DRAPE
K112378 · KKX
Cobes Industries Co., Ltd.
General Hospital · 264d
Cleared May 08, 2012
AMSCO CHIMERON MEDIUM STEAM STERLILZER
K112403 · FLE
STERIS Corporation
General Hospital · 260d
Cleared May 08, 2012
NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX
K113451 · HKI
Nidek Technologies Srl
Ophthalmic · 169d
Cleared May 08, 2012
CALCIUM GEN. 2
K113521 · CHW
Roche Diagnostics
Chemistry · 161d
Cleared May 08, 2012
MERITS MODEL R SERIES POSITIONING SYSTEM FOR POWERED WHEELCHAIR
K113577 · ITI
Merits Health Products Co., Ltd.
Physical Medicine · 155d
Cleared May 08, 2012
C2 MEDICAL GLOVES
K113639 · LZA
Amercare, Inc.
General Hospital · 151d
Cleared May 08, 2012
ELEMENT BLOOD GLUCOSE MONITORING SYSTEM
K113670 · CGA
Infopia Co, Ltd.
Chemistry · 147d
Cleared May 08, 2012
RANDOX COCAINE METABOLITE
K113751 · DIO
Randox Laboratories, Ltd.
Chemistry · 139d
Cleared May 08, 2012
G+ SYSTEM
K113853 · NDC
Glytec, LLC
General Hospital · 131d
Cleared May 08, 2012
PERFORMER HT/ HANG&GO HT BASIC
K120026 · LGZ
Rand S.R.L.
General Hospital · 126d
Cleared May 08, 2012
VENOUS DRAINAGE CANNULA WITH DURAFLO COATING
K120072 · DWF
Edwards Lifesciences, LLC
Cardiovascular · 119d